| Editor's Note: Fierce Biotech is monitoring the FDA's advisory meeting for Sarepta Therapeutics' DMD gene therapy. Check our website this evening for the latest news. |
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Unleash the Full Potential of Your Data! Our BioELN Solution maximizes your success with efficient resources and knowledge management. Transform data into discoveries with Signals Notebook. Learn more in our white paper. 
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Today's Big NewsMay 12, 2023 |
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Wednesday, May 17, 2023 2:00pm ET / 11:00am PT Join this webinar to learn more about the opprtunity medical affairs teams and medical science liaisons (MSLs) have to engage with HCPs in clinical discussions and bridge care gaps by providing crucial insights into evidence-based medicine. Register now to learn more. 
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| By Angus Liu The U.S. Senate’s Health, Education, Labor & Pensions (HELP) Committee voted on Thursday to advance a basket of bipartisan bills with the goal to tighten rules that have benefited pharma companies and pharmacy benefit managers and introduce new ones to increase transparency. |
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By Nick Paul Taylor GSK has shared pivotal data that could help fend off Pfizer’s attack on its blockbuster vaccine franchise. The phase 3 results show the five-in-one meningitis vaccine is immunologically effective against the most common strains, keeping GSK tucked in behind Pfizer in the race to market. |
By Kevin Dunleavy Amid reports that the pharma industry is preparing a legal challenge to drug price negotiation measures in the Inflation Reduction Act, Pfizer CEO Albert Bourla blasted the plan, calling it “negotiation with a gun to your head" at a Reuters event. |
By Helen Floersh Novo Nordisk’s Ozempic and Wegovy may have benefits beyond helping patients shed pounds: They appear to reverse the impairments in cancer-fighting natural killer cells seen in people with obesity, independent of weight loss. |
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Tuesday, May 23, 2023 | 2pm ET / 11am PT Clinical trials are complex, time-consuming, and costly. But what if you could use simulation to guide your decisions and optimize your trial design? In this webinar, we'll discuss the power of simulation-guided trial design (SGTD) and explain its benefits to clinical development strategies. Register now to join us. 
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By Kevin Dunleavy The race is on for companies hoping to get vaccines to the market this fall for the start of the respiratory syncytial virus season. Sanofi and AstraZeneca have taken another step toward that goal, revealing strong data from a real-world trial of their candidate nirsevimab. |
By Ben Adams Around 40% of liver disease posts on social media site TikTok contain misinformation in a worrying trend doctors want to reverse. |
By Annalee Armstrong Algorithm Sciences is no longer planning to set up a base on Hoth Therapeutics, as the two small biotechs terminate a planned merger. |
By Fraiser Kansteiner Bracing for losses of exclusivity on a pair of drugs this year, Takeda has forecasted 3,840 billion yen (about $28.5 billion) in revenues for fiscal year 2023, an expected 4.7% drop from the sum the company reported in 2022. |
By Gabrielle Masson ‘Tis the season—earnings season that is. A time of pipeline culls, project delays and partnership terminations—and this quarter has been no exception, with two more biotechs reporting changes today. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we're concluding our miniseries on Narcan the nasal spray. It is the first naloxone product to be approved for use without a prescription. |
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Thursday, May 25, 2023 | 10:00am ET / 7:00am PT Join the webinar and discover our MVA technology platform and explore the advantages for development and manufacturing of multiple vaccines and cell and gene therapeutics. Register now. 
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Whitepaper ChatGPT shows promise in drug discovery for information extraction, scientific text authoring, hypothesis prediction, and chemical entity prediction. This whitepaper explores its potential to streamline research, delving into its technology, applications, and limitations. Sponsored by: Elucidata Corp., Cloud SAAS in Life Sciences R&D |
eBook Discover a game-changing approach to clinical research with Hybrid and Decentralized Clinical Trials (DCTs). Learn about the benefits, challenges, and key elements for success. Sponsored by: EvidentIQ |
Research What role do the Library and Legal teams play in the drug development pipeline at Lilly? An import one – find out how. Sponsored by: CCC |
Whitepaper This paper focuses on stakeholder engagement and how Medical Affairs teams’ responsibilities, goals, tools, and techniques are changing. Sponsored by: Blue Matter, strategic consultants in the life sciences |
Research Strategies for Optimal Site Selection and Feasibility Research in Novel Therapies and Geographies Sponsored by: H1 |
Whitepaper How can eConsent provide a more flexible approach to informed consent? Sponsored by: YPrime |
Whitepaper Preparation of critical process liquids and buffer components shifts resources away from core activities and can be filled with inefficiencies and risks that can increase time and costs across your workflow. Learn about the framework to help reduce your total costs beyond capital and operational expenditures and set a solid foundation for successful scale-up of buffer preparation. Sponsored by: Thermo Scientific Production Chemicals and Services |
Whitepaper Explore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment. Sponsored by: Catalent Clinical Supply |
Whitepaper Discover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
Whitepaper As sponsors increasingly look to CROs to support their clinical studies, making and addressing certain clinical supply considerations at the outset of the relationship can reduce the risk of potentially unforeseen impact to budget and time later. Discover key issues sponsors should consider to help their CRO or partner of choice better understand their clinical supply needs. Sponsored by: Catalent |
Whitepaper For sponsors, cost is a key concern when it comes to managing the supply of their clinical trials. A financial project analyst (FPA) is a specialized expert who can help control clinical supply costs and keep the project within budget. Explore the critical role that a Financial Project Analyst plays in clinical trial supply and budget management. Sponsored by: Catalent |
Whitepaper Learn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region. Sponsored by: Catalent |
Whitepaper How can specialized expertise help you optimize your clinical supply chain? Learn about the roles and responsibilities of unique experts such as clinical supply management, project management, and financial project analysis. Sponsored by: Catalent Clinical Supply |
Whitepaper Planning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial. Sponsored by: Catalent |
Whitepaper Explore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world. Sponsored by: Catalent |
| July 18-19, 2023 | Jersey City, NJ |
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